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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Type Device Class Implantable

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Cambria™ - 10889910057956

Cambria Implant, 17mm x 13mm x 7mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
39-1707
Not in Commercial Distribution

  • 10889910057956 ()

  • 17mm x 13mm x 7mm
39-1707

  • Vertebral body prosthesis, non-sterile

Cambria™ - 10889910057949

Cambria Implant, 17mm x 13mm x 6mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
39-1706
Not in Commercial Distribution

  • 10889910057949 ()

  • 17mm x 13mm x 6mm
39-1706

  • Vertebral body prosthesis, non-sterile

Cambria™ - 10889910057994

Cambria Implant, 17mm x 13mm x 11mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
39-1711
Not in Commercial Distribution

  • 10889910057994 ()

  • 17mm x 13mm x 11mm
39-1711

  • Vertebral body prosthesis, non-sterile

Cambria™ - 10889910057932

Cambria Implant, 17mm x 13mm x 5mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
39-1705
Not in Commercial Distribution

  • 10889910057932 ()

  • 17mm x 13mm x 5mm
39-1705

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059165

S2S CrossBar, 33 - 47mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-2023
Not in Commercial Distribution

  • 10889910059165 ()

  • 33 - 47mm
50-2023

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059158

S2S CrossBar, 27 - 35mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-2022
Not in Commercial Distribution

  • 10889910059158 ()

  • 27 - 35mm
50-2022

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059141

S2S CrossBar, 24 - 29mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059134

Sierra Set Screw. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-1005
Not in Commercial Distribution

  • 10889910059134 ()
50-1005

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059127

Axial Rod Connector, 3.5/6.35. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-0935
Not in Commercial Distribution

  • 10889910059127 ()

  • 3.5/6.35
50-0935

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059110

Axial Rod Connector, 3.5/5.5. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-0835
Not in Commercial Distribution

  • 10889910059110 ()

  • 3.5/5.5
50-0835

  • Vertebral body prosthesis, non-sterile
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